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Proposal for Law No 101 /XII

Exhibition of Motives

Over the past 50 years, organ transplantation has generalized worldwide,

providing great therapeutic benefits to hundreds of thousands of patients. The

organ transplantation is the treatment with a better cost-effectiveness in cases

of chronic terminal renal insufficiency, the only treatment being available in the cases of

terminal insufficiency of organs such as the liver, the lungs and the heart.

However, the transplantation of organs carries risks. The vast therapeutic use of

human organs for transplantation requires that quality and safety be ensured

of these organs in such a way as to minimise any risks of transmitting diseases.

In this sense, the gift, harvesting, characterization, analysis, preservation, transport and

transplantation of organs of human origin must meet high standards of quality and

safety, so as to ensure a high level of protection of human health and prevent the

transmission of diseases through these organs.

It is still essential, to ensure the quality and safety of the organs, that the transplantation of

organs based on the principles of voluntary and gratuitous donation, and that is ensured to the

living donors as much protection as possible, thereby respecting the dignity of the person, in the

plasmoned terms in the Convention on Human Rights and Biomedicine, well

as of its Additional Protocol concerning the Transplantation of Organs.

Being necessary to ensure that organs of human origin intended for transplantation

present quality and safety criteria common to all Member States, the

European Parliament and the Council of the European Union have approved the Directive

n. 2010 /53/UE of July 7, 2010 on quality and safety standards of the

human organs intended for transplantation.

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With a view to the fulfilment of European requirements as well as to the promotion of application

effective of the provisions laid down in this diploma, is established, still, a regime of

applicable sanctions in the event of infringement.

The hearing was promoted by the National Data Protection Commission, of the Council

National Ethics for Life Sciences, the Order of Physicians and the Society

Portuguese of Transplantation.

Thus:

Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the

Assembly of the Republic the following proposal for a law:

CHAPTER I

General provisions

Article 1.

Object

1-A present law establishes standards that aim to ensure the quality and safety of organs

of human origin intended for transplantation in the human body, so as to ensure

a high level of protection of human health.

2-A This Law transposes to the internal legal order the Directive No 2010 /53/UE of the

European Parliament and of the Council of July 7, 2010 on standards of

quality and safety of human organs intended for transplantation.

Article 2.

Scope of application

1-The provisions of this Law shall apply to the donation, harvesting, characterization, analysis,

preservation, transport and implantation of organs of human origin intended for

transplantation in the human body.

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2-The provisions of this Law shall not apply to the use of organs for the purposes of research,

except if the same ones are intended for transplantation in the human body.

Article 3.

Definitions

For the purposes of this Act, it shall be understood by:

a) "Characterization of the donor", the collection of relevant information on the

characteristics of the donor, necessary to assess their suitability for the gift of

organs, effecters an appropriate risk assessment and minimise the risks to the

receiver, as well as to optimize organ allocation;

b) "Characterization of the organ", the collection of relevant information on the

characteristics of the organ required to assess suitability, to effect an

proper assessment and minimise the risks to the receiver and optimize the assignment

of organs;

c) "Centres of blood and transplantation", services territorially

de-concentrates of the Portuguese Institute of Blood and Transplantation, I.P. (IPST,

I.P.), to whom it competes, in accordance with Portaria No 165/2012 of May 22,

in the area of transplantation:

i) Ensure the laboratory study of donors and candidate patients to

organ transplantation;

ii) Ensure the maintenance of the necessary conditions for the choice of the pair

donor / recetor in renal transplantation;

iii) Accompany the transplantation of organs;

d) "Harvest" means the process by which the donated organs are made available;

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e) "Hospital coordinator of donation", licensed in medicine, with training

specific to the detection and evaluation of potential organ and tissue donors

for transplantation, preferentially from the areas of intensive care,

urgency, emergency or anaesthesia, whose competences are defined in the

Portaria No. 357/2008 of May 9, which integrates the National Network of

Coordination of Harvest and Transplantation;

f) "Dádiva", the donation of organs for transplantation;

g) "Dador", the person who makes gift of one or several organs, wants the gift to occur

during the life, either after the death of that person;

h) "Disposal", the final destination given to an organ when this is not used for

transplantation;

i) "Harvesting and transplantation coordinators offices", autonomous structures

endowed with specialized human resources in the area of harvesting coordination

and transplantation, and of pluridisciplinary teams for the realization of the harvest of

organs, tissues and cells in the identified donors, whose competences are

they are set out in the Portaria No. 357/2008 of May 9, which integrate the

National Network for Coordination of Harvest and Transplantation;

j) "Serious adverse incident", an undesirable and unexpected occurrence associated with

any stage of the process, from the donation to the transplantation, susceptible to

lead to the transmission of an infective disease, to death or to situations of danger of

life, disability or disability of the patient or to provoke or prolong his / her

hospitalization or morbidity;

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k) 'Harvesting Organism', a health care establishment, a team

or a unit of a hospital or any other body that will proceed to

collection of organs or their coordination and which is authorized to do so by the

Directorate General of Health (DGS);

l) "European Organisation for organ exchange", a non-purpose organisation

lucrative, public or private, dedicated to national exchange or

cross-border of organs and whose member countries are majority-owned

Member States;

m) "Organ", a differentiated part of the human body, consisting of several

tissues, which maintains, in a significantly autonomous way, its structure,

vascularization and ability to develop physiological functions, including the

parts of organs that have as a function to be used to serve the same

goal that the entire organ in the human body, maintaining the conditions of

structure and vascularization;

n) "Preservation", the use of chemical agents, the change of conditions

environmental or other means intended to prevent or retard deterioration

biological or physical organs of human organs, from the harvest to the transplantation;

o) "Operational procedures", written instructions describing the steps of

a specific process, including the materials and methods to be used and the result

expected final;

p) "Traceability", the ability to find and identify the organ at each step

of the process, from the donation to the transplantation or disposal, including the

ability to:

i) Identify the donor and the harvesting body;

ii) Identify the receiver in the transplantation centre; and

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iii) Find and identify all relevant non-personal information,

related to the products and materials that come into contact with the

organ;

q) "Serious adverse reaction", an undesirable and unexpected response, including a

infectious-disease, from the living donor or the receiver, who may be associated with any

process step, from the donation to the transplantation, which causes death or endanger

life in danger, lead to a disability or disability or that provokes or

extend the hospitalization or morbidity;

r) "Receiver", person who receives the transplantation of an organ;

s) "Transplantation", the process intended for the restoration of certain functions of the

human organism, upon the transfer of an organ from a donor to a

receiver;

t) "Harvesting unit", the units in which is authorized the harvesting activity of

organs of human origin for the purposes of transplantation, by DGS;

u) "Transplantation unit", a health care establishment, a

team or a unit of a hospital or other body that will proceed to

organ transplantation and that is authorized to do so by DGS.

CHAPTER II

Principles governing the donation of organs

Article 4.

Principles applicable

1-Without prejudice to the provisions of Article 5 (3) of the Law No 12/93 of April 22, amended

and Republicated by Law No. 22/2007 of June 29 and the provisions of the figures

following, the donation of organs is voluntary and unpaid.

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2-Living donors are entitled to receive strictly limited compensation to be covered

the expenses incurred and the loss of donations related to the donation.

3-The conditions under which the compensation provided for in the preceding paragraph may be granted

are defined by dispatch of the member of the Government responsible for the area of health, not

may constitute an incentive or financial benefit to a potential donor.

4-The living donor is always entitled to be indemnified for damages arising from the

process of donation and harvesting, regardless of fault, pursuant to Art. 9 para.

Law No. 12/93 of April 22, amended and Republicated by Law No. 22/2007, 29 of

June.

5-A The activity developed by the harvesting units cannot have lucrative character.

6-A The promotion of organ donation should be done under Article 15 of the Law

n ° 12/93 of April 22, amended and Republicated by Law No. 22/2007 of June 29.

7-It is prohibited advertising on the need for organs or on their availability,

when it is intended to offer or seek to obtain financial profits or advantages

equivalents.

CHAPTER III

Competent authority

Article 5.

Designation and functions of the competent authority

1-A competent authority responsible for verifying compliance with the requirements

provided for in this Law in the entire national territory is DGS, without prejudice to the

articulation with the Inspectorate-General of Activities in Health, abbreviated

by IGAS, in the matter of surveillance and inspection.

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2-Compete to DGS, as a competent authority, namely:

a) Establish and keep up to date a system for the quality and safety that

cover all steps of the process, from the donation to the transplantation or

elimination of the organ, including the definition of operating procedures to which

refers to Article 9;

b) Authorize the harvesting units and transplantation units, according

with the present law, upon assent of the Portuguese Blood Institute of Blood

and of Transplantation, I.P., abbreviately designated by IPST, I.P., while

entity responsible for strategic planning of response to needs

national;

c) To ensure that the harvesting units and transplantation units, the

Coordinators of Harvest and Transplantation offices, abbreviated

designated by GCCT and the Blood and Transplantation Centres,

abbreviately designated by CST, be subjected to control measures

or regular audits in order to check the fulfilment of the requirements,

guidelines or guidelines issued by the DGS and the IPST, I.P., pursuant to the

present law;

d) Suspend or revoke the authorisations granted to the harvesting units and to the

transplantation units, should the control measures demonstrate that not

comply with the requirements set out in this Law;

e) Establish a system of notification and management of adverse incidents and reactions

serious, under the terms of Article 14, compatible with the information system of the

IPST, I.P., referred to in Article 6;

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f) Issue guidelines aimed at the harvesting units and the units of

transplantation and health professionals and other people involved in all

steps of the transplantation process, from the donation to the transplantation or

disposal of organs, including guidelines for the collection of pre- and

relevant post-transplantation to assess the quality and safety of organs

transplanted;

g) Participate in the network of competent authorities of the European Union, whose creation

is found to be provided for in Article 19 (1) of Directive No 2010 /53/UE of the

European Parliament and of the Council of July 7, 2010;

h) Scrutinizing the exchange of organs with other Member States and with countries

third parties, pursuant to this Law.

3-It is set up with the DGS a Technical Advisory Group with the competence to support

technical and scientifically the exercise of the functions of competent authority, whose scope

of intervention, composition and operation are defined by the Director-General of the

Health.

4-Members of the Advisory Technical Group are not remunerated, without prejudice to the

right to the payment of expenses with the displacements, arising from the functions

exercised, in the terms provided for the generality of employees in office

public.

Article 6.

Records and reports relating to the harvesting units and transplantation units

1-The IPST, I.P., is the entity responsible for ensuring the operation of a system of

unique and integrated information in the field of harvesting and transplantation, designated by

Portuguese Registration of Transplantation (RPT).

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2-The RPT includes the data referred to in articles 13, 14, 17 and 18.

3-The RPT further integrates data relating to the activities of the harvesting units and the

transplantation units, specifically aggregated data on the number of

donors, as well as the type and quantity of organs harvested and transplanted or

eliminated, in accordance with the applicable data protection provisions

personal and statistical secret.

4-The RPT allows IPST, I.P., the management of the waiting list of candidate patients to

transplantation, selection of the donor pair / receptor in transplantation, tissue bank and

traceability, pursuant to the provisions of the paragraph o) of Article 3 (2) of the Decree-Law

n. 39/2012, of February 16.

5-The IPST, I.P., guarantees to DGS the access to information contained in the RPT.

6-RPT access levels are defined in articulation between the IPST, I.P., and the DGS and

submitted a authorisation pursuant to Law No 67/98 of October 26.

7-A DGS and the IPST, I.P., draw up public and periodic reports of activities of their

areas of competence.

8-Whenever requested by the European Commission or by another Member State, the IPST,

I.P., and DGS provide information on the record of the harvesting units and the

transplantation units.

Article 7.

Authorization

1-Compete to DGS authorize the harvesting units and transplantation units, from

agreement with this Law, upon assent of the IPST, I.P., as an entity

responsible for strategic planning of response to national needs.

2-A Authorization of organ harvesting activity on corpse donor can only be

granted to harvesting units that have the following requirements:

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a) Intensive care unit or other hospital services where if

provide ventilatory support care;

b) Hospital coordinator of donation, for whose appointment the opinion is required

previous IPST, I.P., in the framework of its allocation of participating in the definition

global strategic development of transplantation;

c) Qualified professionals;

d) Protocol established with the hospital where you are seated the GCCT of your

reference area, with which the unit is to be articulated for referencing of

all potential organ donors, pursuant to the Portaria No. 357/2008, of 9

of May.

3-All establishments that have ventilatory support care are

required to, within 60 days of the entry into force of this Law or of the

creation of the unit, communicate to IPST, I.P., for the purposes of appearing before, its

immediate availability for the realization of organ harvesting.

4-The favourable opinion of the IPST, I.P., is referred to DGS, at the end of the harvesting activity of

organs being authorized.

5-A organ transplantation activity can only be authorized in the units that

meet the following requirements:

a) General requirements:

i) Facilities, equipment and interdisciplinary supports required,

specifically, intensive care, surgical, anaesthetics and means

diagnostic supplementation appropriate to the type of transplant so that

if you ask for authorization;

ii) A medical officer by the transplantation programme with training and

specific experience in the area;

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iii) Qualified professionals.

b) Minimum specific requirements:

i) Cardiac transplantation: existence of a surgery service

cardiothoracic with surgical, cardiologic, intensive care support

and complementary means of diagnosis, and must articulate,

preferentially, with a unit of heart failure;

ii) Pulmonary transplantation: requirements equal to those referred to the transplantation

cardiac, with support of pneumology and microbiology;

iii) Renal transplantation: existence of a nephrology service with

possibility of conducting dialysis;

iv) Reno-pancreatic transplantation and pancreatic transplantation: existence

of a nephrology service with possibility of conducting dialysis,

integrated into a renal transplant unit, in articulation with a

endocrinology unit;

v) Hepatic transplantation: existence of a service with experience in

abdominal surgery, with supports of hepatology, immunohematology,

infecology and medical oncology, with availability of techniques from

endoscopy and imaging;

vi) Multivisceral and intestine multiple transplantation: existence of a

service with experience of transplantation;

vii) Pediatric transplantation: realization in paediatric hospital environment,

signing up within specific programs of centres with a wide

experience in the area of the different types of transplantation (heart, lung,

kidney, pancreas, liver, intestine or other organs).

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6-The minimum number of transplants to be carried out in the transplantation units is defined

by DGS, taking into account the European and international standards of quality and

security that the evidence recommends.

7-The application for permission for the transplantation activity is presented by the

maximum responsible for the health establishment, upon application addressed to the

DGS, from him owing to the following information:

a) Type of transplant to be carried out;

b) Identification of the medical officer by the transplant team and the respect

curriculum vitae ;

c) Qualifications of the remaining personnel involved or to involve in the activity;

d) Annual plan of activities, including with respect to the number of transplants that

proposes to carry out;

e) Descriptive memory where it consents the identification of the facilities, equipment and

interdisciplinary supports that the health establishment has for

develop the activity, in accordance with the requirements set out in paragraph 5 of the

present article.

8-Addressing harvesting activity, the requirement referred to in the preceding paragraph is

accompanied by the elements referred to in paragraph 2.

9-A DGS proceeds to the issuance of the authorization, indicating the authorized activities.

10-Harvesting units and transplantation units may not proceed to

any substantial change in its activities without the prior approval of DGS.

11-The harvesting units and transplantation units present to the DGS, up to the

last day of the month following the year to which they respect, an annual report of its

activities, which is an integral part of the assessment necessary to the maintenance of the

authorization of exercise of activity.

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Article 8.

Measures of control

1-A DGS ensures, in articulation with IGAS, the periodic realization of audits,

inspections or other control measures appropriate to the harvesting units and to the

transplantation units, the GCCT and CST, in order to ensure compliance with the

provisions of this Law.

2-A DGS notifies in writing the responsible of the services referred to in the preceding paragraph

of the result of the audits and inspections effectuated.

3-A DGS sets out the guidelines regarding the conditions of auditing, inspection or other

control measures, as well as the training and qualification of the professionals involved,

in order to guarantee a high competence and performance, in articulation with IGAS.

4-In the event of adverse reactions or serious or suspected incidents of them, the DGS

guarantees the carrying out of audits, inspections or other control measures.

5-A DGS guarantees the carrying out of audits, inspections or other control measures to

request from the competent authorities of another Member State, as long as justified.

6-Whenever requested by another Member State or by the European Commission, the DGS

provides information on the results of inspections and control measures

related to the requirements set out in this Law.

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CHAPTER IV

Quality and safety of organs

Article 9.

Regime for quality and safety

1-Harvesting units and transplantation units, the GCCT and the CST shall, in the

scope of your area of acting, implement and keep up to date a system for the

quality and safety, in accordance with the system established at the national level by DGS,

referred to in para. a) of Article 5 (2), including the application of procedures

operational to:

a) Check the identity of the donor;

b) Check the information relating to consent, authorization or non-existence

of objections from the donor or his family, in accordance with the one established in law, in the

place where the donation and harvesting took place;

c) Check that the characterization of organs and donors was carried out, such as

provided for in Article 11;

d) The harvesting, preservation, packaging and labeling of organs, according to the

articles 10 and 12;

e) The transport of human organs, as provided for in Article 12;

f) The exact, quick and verifiable notification of serious adverse reactions and adverse events,

as provided for in Article 14 and in Article 17 (7);

g) The management of serious adverse reactions and adverse incidents, as provided for in paragraph 2 of the

article 14;

h) Ensure traceability, from the donor to the recetor and vice versa, on the terms

of Article 13;

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i) To ensure the security and confidentiality of personal data concerning the

donors and receivers, pursuant to Art. 18 para.

2-The operating procedures referred to in points f) , g) , h) and i) of the previous number

specify, inter alia, the responsibilities of the harvesting units and the units

of transplantation and the European organ exchange organisations.

3-Harvest units and transplantation units, the GCCT and CST adopt the

necessary measures to ensure that the documentation relating to procedures

operational referred to in the preceding paragraphs is available at the

audits, inspections or other control measures carried out within the framework of this Law.

Article 10.

Harvesting of organs

1-Harvesting units ensure that the selection and evaluation of donors are effectuated

under the counseling and guidance of the donation hospital coordinator, in the case of

dador corpse.

2-A organ harvesting is carried out in operating rooms designed, built, maintained and

managed in accordance with applicable law and with the standards of good clinical practice, of

mode to ensure the quality and safety of the harvested organs.

3-The materials and equipment used in the harvest are treated in accordance with

applicable legislation on sterilization of medical devices.

Article 11.

Characterization of organs and donors

1-The donor organs and respects are characterized prior to transplantation, upon

the collection of the set of data set out in Part A of Annex I to this Law, of which

is an integral part.

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2-In addition to the minimum set of data referred to in the preceding paragraph, the medical team,

where necessary and taking into account the availability of the information and the

particular circumstances of each case, proceeds to the collection of the information provided in the

Part B of Annex I to this Law.

3-In the emergency situations, duly substantiated from the clinical point of view, in

that, according to a benefit-risk analysis, the expected benefits for the receiver

overcoming the risks arising from incomplete data, may be considered for

transplantation the organs in relation to which no data are available

minimums referred to in Part A of Annex I to this Law.

4-To comply with the quality and safety requirements provided for in this Law, the team

medical:

a) It obtains from the living donors all the necessary information, supplying them, to

the effect, the information that they need to understand the consequences of the

dondiva;

b) Search for information from the donor's relatives or other people, in the

case of donors post mortem , where possible and appropriate;

c) Sensitizes all the people to whom information is requested for the importance

of the rapid transmission of them.

5-Laboratory tests required for organ transplantation are carried out by

laboratories of the IPST, I.P., which have facilities and equipment and

appropriate operational procedures to ensure that the information regarding the

characterization of organs and donors are transmitted to the transplantation units in

useful time.

6-Transplantation units check, before they proceed to transplantation, if the

characterization of the organ and the donor was carried out and registered, pursuant to this Law.

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Article 12.

Transport of organs

1-The bodies, entities or companies involved in the transport of organs have

of appropriate operating procedures to ensure the integrity of the organs

during transport and a suitable transport time, according to the system

referred to in Article 9, being subject to licensing and inspection, in terms of defining

by porterie of the member of the Government responsible for the area of health.

2-The containers used for the transport of organs are labeled with the following

information:

a) Identification of the harvesting unit, including date and time, and of the unit of

health where it was held, including the respected addresses and numbers of

telephone;

b) Identification of the target transplantation unit, including unit of

health where it is installed, address and telephone number;

c) Indication that the packaging contains an organ, specifying the type of organ

and, where applicable, your location on the left or the right, and include the sentence

HANDLE WITH CARE;

d) The appropriate conditions of transport, in order to maintain the integrity of the

organ.

3-The transported organs are accompanied by the report on the characterization of the

organ and the donor.

4-The provisions of the b) of paragraph 2 is not chargeable in case of transport of organs within

of the same establishment.

5-Transplantation units check, before they proceed to transplantation, if the

conditions of preservation and transport of the received organs have been fulfilled.

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Article 13.

Traceability

1-The organs harvested and transplanted into the national territory are the object of traceability,

from the donor to the recetor and vice versa, in order to protect the health of donors and the

receivers.

2-For the purposes of the provisions of the preceding paragraph, the harvesting units and the units of

transplantation, the GCCT and the CST dispose, within the scope of the respective area of acting, of

a system for identification of donors and receivers that allows to identify each donation

and each of the organs associated with it in accordance with that provided for in Article 18,

integrated in the RPT.

3-The information system referred to in the preceding paragraph includes the data required for

ensure traceability at all stages of the process and the information on the

characterization of organs and donors set out in Annexes I and II to this Law.

4-The data required to ensure traceability are retained during the

minus 30 years after the donation, regardless of the type of support and since

safeguarded to respect confidentiality and destroyed as soon as they are not required

for traceability effects.

5-In case of exchange of organs between Member States, the transmission of the data

necessary to ensure traceability and information on the characterization of

organs and donors, referred to in paragraph 3, is done in accordance with the defined procedures

in accordance with Article 29 of Directive No 2010 /53/UE of the European Parliament and of the

Council, of July 7, 2010.

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Article 14.

Systems for notification and management of serious adverse reactions and adverse events

1-Harvesting units and transplantation units, the GCCT and the CST have the

a notification system, in accordance with the one established by the DGS, intended for

communication, research, registration and transmission of the relevant information and

necessary about:

a) Serious adverse events susceptible to influencing the quality and safety of the

organs and which can be attributed to the donation, harvesting, characterization analysis,

preservation and transport of the organs;

b) Any serious adverse reaction, observed during or after the transplantation, which

may be related to harvesting, analysis, characterization, preservation and

transport of the organs.

2-Harvesting units and transplantation units, the GCCT and the CST have the

operating procedures to notify the DGS, within a maximum of 24 hours, of the

reactions and serious adverse events, as well as for their management, including for the

research aimed at analyzing its causes and consequences and the measures adopted.

3-It is up to DGS to monitor and manage the notifications referred to in the preceding paragraph and issue the

necessary alerts in order to be taken the appropriate measures.

4-Harvesting units and transplantation units, the GCCT and the CST ensure

the interconnection between the notification system referred to in paragraph 1 and the notification system

provided for in Article 11 of Law No 12/2009 of March 26.

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5-In the event of an exchange of organs between Member States, the notification of reactions and

serious adverse incidents is done in accordance with the procedures set out in the

terms of Article 25 of Directive No 2010 /53/UE of the European Parliament and of the

Council, of July 7, 2010.

Article 15.

Qualified professionals

1-All personnel of the harvesting and transplantation units have job descriptions

updated that clearly establish the respective missions and responsibilities.

2-Harvesting units and transplantation units assign the responsibility

by the management of respect activities and quality assurance to different persons and

independent of each other.

3-All personnel of the harvesting units and transplantation units are the object of

initial and continuous training appropriate to the respective tasks.

4-It is mandatory for the existence of records of the training provided, which must include

modules referring to good practices.

5-The content of training programmes and the specific competence of professionals are

periodically assessed by the responsible of the harvesting units and the

transplantation.

CHAPTER V

Protection of donor and receiver and donor selection and evaluation

Article 16.

Consent

1-A organ harvesting in living donors can only be effected after they have been met

the requirements relating to the information and consent provided for in Articles 7 and 8 of the

Law No. 12/93 of April 22, amended and Republicated by Law No. 22/2007, 29 of

June.

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2-A harvest post mortem of organs can only be carried out after verification of non-opposition

or non-existence of restrictions to the donation, through consultation of the National Register of No

Donors (RENNDA), pursuant to Article 15 of the Decree-Law No. 244/94, of 26 of

September.

3-The consent of the receiver is provided and obtained in accordance with that provided for in Article 7.

and No. 1 and 2 of Article 8 of Law No 12/93 of April 22, amended and Republicated by the Law

n. 22/2007, of June 29.

4-Addressing minor payers, consent is provided by parents, provided that

not inhibited from the exercise of parental power, or, in the event of inhibition or lack of both,

upon judicial authorization.

5-A organ transplantation in minors with an ability to understand and to

manifestation of will lacks, too, of the concordance of these.

6-A organ transplantation in larger receivers, unable for reasons of anomaly

psychic, can only be done by judicial authorization.

7-The consent of the receiver or of whom lawfully the represent is always provided by

written, being freely revocable.

Article 17.

Quality and aspets related to the safety of the living donor

1-A donation and harvesting of organs in life for therapeutic or transplantation purposes only

carry out in the terms and conditions of Article 6 of Law No 12/93 of April 22, amended

and Republicated by Law No. 22/2007 of June 29.

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2-Living donors are selected on the basis of their state of health and clinical history,

by a multidisciplinary team of the transplantation unit, in specific consultation of

dador alive, the registration of the decision being necessary, in support of integrating the RPT into the

terms of the applicable provisions on the protection of personal data and secrecy

statistical.

3-A The assessment referred to in the preceding paragraph implies the exclusion of persons whose gift

may constitute an unacceptable risk to health.

4-Transplantation units have and keep up to date a donor register

living, in accordance with the one provided for in Article 18, integrated into the RPT.

5-Transplantation units guarantee the follow up of the living donor after the process

of donations and harvesting, and they have a notification system, according to the defined

by DGS under the terms of the paragraph e) of Article 5 (2), intended for communication,

research, registration and transmission of information on:

a) Any event potentially related to the quality and safety of the

donated organ and, consequently, with the safety of the receiver;

b) Any serious adverse reaction, observed in the living donor, that may result from the

dondiva.

6-Transplantation units notify the DGS, within a maximum of 24 hours, of the

reactions and serious adverse events referred to in the preceding paragraph, as well as the

findings from research aimed at analysing their causes and consequences and the

measures adopted.

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Article 18.

Protection of personal data, confidentiality and security of the treatment of

data

1-In the stricture respect for the conditions set out in the Personal Data Protection Act,

approved by Law No. 67/98 of October 26 the personal data relating to donors and

receivers, their treatment and interconnection, are subject to professional secrecy and to measures

adequate security and information confidentiality.

2-To the donor and receiver is guaranteed the confidentiality of all related information

with your health, with the results of the analyses of your donations and with the traceability

of your gift.

3-In the gift post mortem and in the cross-renal donation, the donor or his relatives do not

you may know the identity of the receiver, nor the receiver or your relatives to

identity of the donor, owing to the respected data being the object of encryption or other

means appropriate to ensure the non-intersecting of information.

4-Are expressly prohibited aditations, suppressions or unauthorized changes of the

constant data from donor sheets or exclusion registers, as well as the

unauthorized transfer of information when they fail to comply with the schedule in

Law No. 67/98 of October 26.

5-The information systems provided for in this Law guarantee the security of data.

6-The rights of access and opposition of the data holders to the information contained in us

systems for registration of donations and donors exercise in the terms and conditions referred to

in Articles 11 and ( a) of Article 12 of Law No 67/98 of October 26.

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CHAPTER VI

Exchange of European bodies and organizations of organ exchange

Article 19.

Exchange of organs

1-The exchange of human organs with third countries is subject to permission from the

IPST, I.P., upon favourable opinion of DGS on quality and safety,

in the terms of the following number.

2-The exchange of organs referred to in the preceding paragraph may only be authorized when

check the following circumstances:

a) The organs can be traced from the donor to the recetor and vice-versa;

b) The organs comply with the quality and safety requirements provided for in the present

law or, in the case of third countries, equivalent standards.

3-A DGS guarantees the surveillance of the exchange of organs with other Member States and

with third countries, in accordance with the quality and safety requirements

provided for in this Law.

4-For the purposes of the provisions of the preceding paragraph, DGS may enter into agreements with the

competent authorities with counterparts in other Member States and third countries,

provided that the said authorities ensure compliance with the equivalent requirements

to those provided for in this Law.

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Article 20.

European organ exchange organisations

DGS can enter into agreements with officially recognised organisations at the European level

of organ exchange, provided that the said organizations ensure compliance

of the requirements set out in this Law, in order to delegate to the said organizations,

particularly:

a) The exercise of the activities provided for in the scheme for quality and safety;

b) Specific functions related to the exchange of organs with others

Member States and with third countries;

c) The surveillance of the exchange of organs with other Member States and with

third countries.

CHAPTER VII

Infractions and sanctions

Article 21.

Counterorders

1-To the infractions in the protection of personal data, confidentiality and security

of the data processing is applicable the scheme of counterordinations provided for in the

Law No. 67/98 of October 26.

2-Constitutions lightweight counterorders:

a) The failure to comply with Article 7 (3);

b) The failure to comply with Article 10 (1);

c) The failure to comply with Article 11 (2);

d) The failure to comply with the c) of Article 11 (4);

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e) The failure to comply with the n. and 4 of Article 15.

3-Constituts serious counterordinations:

a) The inobservance of the n. 1, 2 and 5 of Article 4;

b) The failure to comply with Article 7 (11);

c) The failure to comply with points f) a i) of paragraph 1 and paragraph 3 of Article 9;

d) The failure to comply with the points a) and b) of Article 11 (4);

e) The failure to comply with Article 14 (2);

f) The failure to comply with Article 15 (2), 3 and 5 of the Article 15;

g) The failure to comply with the provisions of Article 16 (5) and (6);

h) The failure to comply with Article 17 (2), 5 and 6 of the Article;

i) The infractions that have served to facilitate or cover up light infractions;

j) The recidivism in the practice of light infractions in the last six months.

4-Constitutions very serious counterordinations:

a) The inobservance of the n. 4 and 7 of Article 4;

b) The operation of harvesting units and transplantation units without the

authorization of the DGS, pursuant to Article 7 (1) and (10);

c) The failure to comply with points a) a e) of Article 9 (1);

d) The failure to comply with Article 10 (2) and (3).

e) The failure to comply with Article 11 (1);

f) The absence of the statement of reasons provided for in Article 11 (3);

g) The failure to comply with Article 11 (5);

h) The failure to comply with Article 11 (6);

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i) The failure to comply with Articles 12 and 13;

j) The failure to comply with Article 14 (1);

k) The failure to comply with the provisions of paragraph 1, 2, 3, 4 of Article 16;

l) The failure to comply with Article 17 (3), 4 and 5 of the Article 17;

m) The failure to comply with Article 19 (1);

n) The infractions that have served to facilitate or cover up serious infractions or

very serious;

o) The recidivism in the practice of serious offences in the last five years.

5-In the counter-ordinations provided for in the preceding paragraphs are punishable by negligence and the

attempt, being the amounts of the fines referred to in the following article reduced to

half.

Article 22.

Fines

The counterordinations provided for in the previous article are punishable with fines according to the

next graduation:

a) Lightweight counterorders are punishable by fines up to € 750;

b) Serious counterorders are punishable by fines from € 750 to € 10000, to

natural persons, and up to € 22500, for collective persons;

c) Very serious counterorders are punishable with fines since € 22500 until

€ 35000, for natural persons, and up to € 66000, for collective persons.

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Article 23.

Supervision, instruction and application of fines

1-Compete to IGAS to ensure the monitoring of compliance with the constant provisions

of this Law and the application of the penalties provided for in this Chapter.

2-A IGAS is the competent entity to instruct the counterordinance processes whose

establishment has been determined by DGS or IPST, I.P.

Article 24.

Target of the product of the fines

The product of the fines provided for in this Law reverses:

a) In 60% for the State;

b) In 30% for the DGS;

c) In 10% for IGAS.

Chapter VIII

Transitional and final provisions

Article 25.

Transient standard

1-Harvesting units and transplantation units already in operation have

of a period of 12 months, counted as from the date of the publication of this Law, to

adapt to the requirements set out in it.

2-After the period referred to in the preceding paragraph the health units where they are located

installed the harvesting units and the transplantation units have one

maximum period of thirty working days to apply for the DGS under Article 7, the

renewal of the application for the authorization of the activities in accordance with the schedule in

present law.

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3-The provisions of the preceding paragraphs shall not preclude the harvesting units and centres

of transplantation already in operation may apply for renewal of the authorisation

before the adjustment period provided for in paragraph 1, if they meet the requirements

provided for in this Law.

Article 26.

Abrogation standard

Paragraphs 3 and 4 of Article 3 of Law No 12/93 of April 22, amended and repealed are hereby repealed.

republished by Law No. 22/2007 of June 29, and Portaria No. 31/2002 of January 8,

with the exception of Article 9 para.

Article 27.

Regulation

The regulation provided for in this Act is approved within 120 days of its

entry into force.

Article 28.

Entry into force

This Law shall come into force on the day following that of its publication.

Seen and approved in Council of Ministers of September 27, 2012

The Prime Minister

The Deputy Minister and Parliamentary Affairs

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ANNEX I

(referred to in Article 11)

Characterization of organs and donors

Part A

Minimum set of data to be collected

Minimum set of data-information aimed at the characterization of organs and donors

to collect for each donation, as required in Article 11 (1) and without prejudice to the

provisions of Article 11 (2)

Minimum set of data

Establishment where harvesting and other general character data has been carried out

Date and time of harvest for each organ

Type of donor

Blood group

Sex

Cause of death

Date of death

Date of birth or estimated age

Weight

Height

History present or past of drug use by intravenous (IV)

History present or past of malignated neoplasia

Present history of other communicable diseases

VIH, VHC, VHB tests

Basic information to evaluate the function of the donated organ

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PART B

Complementary set of data

Complementary set of data-information aimed at the characterization of organs and

donors to be collected in addition to the minimum set of data specified in Part A, with

basis in the decision of the medical team, taking into account the availability of the information and the

particular circumstances of the case, pursuant to Art. 11 (2)

Complementary set of data

General data

Information regarding the contact of the body / establishment where it was held

harvesting necessary for the coordination, allocation and traceability of donor organs to the

receivers and vice versa.

Data concerning the donor

Demographic and anthropometric data needed to ensure a compatibility

suitable between organ / donor and receiver.

Clinical history of the donor

Clinical history of the donor, in particular of pathologies that may affect the suitability of the

organs for transplantation and involves the risk of transmission of disease.

Physical and clinical data

Data from the clinical examination required for the assessment of physiological maintenance of the potential

donor, as well as any discovery that reveals illnesses not detached during the analysis

of the clinical history of the donor and which may affect the suitability of the organs for

transplantation or imply the risk of transmission of disease.

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Laboratory parameters

Data required for the evaluation of the functional characterization of organs and the dethetion of

potentially communicable diseases and possible contraindications to organ donation.

Imaging examinations

Imaging examinations necessary for the evaluation of the anatomical state of the organs for

transplant.

Therapeutics

Dador-administered and relevant treatments for the assessment of the functional status of the

organs and suitability for organ donation, in particular the use of antibiotics, substances of

inotropic support or therapeutic transfusion.

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ANNEX II

(referred to in Article 13)

Information on the minimum data about the donor / receiver to be kept

A. By the organ harvesting units

Identification of the donor

Identification of the donation that will include at least:

-Identification of the harvesting organism

-Code of harvesting

-Date of harvest

-Place of harvest

-Type of donation (for example, an organ or various organs; living donors or donors

corpse)

-Date of distribution or elimination

-Identification of the transplantation center to which the organs were distributed.

B. By the organ transplantation centres

Identification of the receiver

Identification of the harvesting unit of supplier organs

Date of distribution or disposal

Identification of the Clinic or end user / Installation.

Type of organ

Date of transplantation or disposal